PDF(Pubmed)
Abstract：
UNASSIGNED: Real-world, observational studies have investigated the safety profile of Direct Oral Anticoagulants (DOACs) on Major Hemorrhage (MH) used for stroke prevention in Non-Valvular Atrial Fibrillation (NVAF). We performed a systematic review and meta-analysis to investigate the comparative safety of DOACs versus other DOACs and versus Vitamin K Antagonists (VKAs) adhering to PRISMA guidelines. We defined MH according to the International Society on Thrombosis and Haemostasis statement or as the composite outcome of intracranial, gastrointestinal, genitourinary, respiratory, cavitary and musculoskeletal bleeding in case of studies using International Statistical Classification of Diseases codes for patient selection.
UNASSIGNED: We systematically investigated two databases (Medline, Embase) until April of 2021, gathered observational studies and extracted hazard ratios (HRs) with 95% confidence intervals (CI) on our outcome of interest. Additional subgroup analyses according to DOAC dosing, prior diagnosis of chronic kidney disease, prior diagnosis of stroke, history of previous use of VKA, the users\' age, the users\' gender and study population geographic region were conducted. All analyses were performed with a random-effects model.
UNASSIGNED: From this search, 55 studies were included and 76 comparisons were performed. The MH risk associated with Rivaroxaban use was higher than the risk with Dabigatran use (HR: 1.32, 95% CI: 1.21-1.45, I 2 : 12.39%) but similar to VKA use (HR: 0.94, 95% CI: 0.87-1.02, I 2 : 76.57%). The MH risk associated with Dabigatran use was lower than the risk with VKA use (HR: 0.75, 95% CI: 0.64-0.90, I 2 : 87.57%). The MH risk associated with Apixaban use was lower than the risk with Dabigatran use (HR: 0.75, 95% CI: 0.64-0.88, I 2 : 58.66%), with Rivaroxaban use (HR: 0.58, 95% CI: 0.50-0.68, I 2 : 74.16%) and with VKA use (HR: 0.60, 95% CI: 0.55-0.65, I 2 : 58.83%). Our aforementioned subgroup analyses revealed similar results.
UNASSIGNED: All in all, Apixaban was associated with a reduced MH risk compared to Dabigatran, Rivaroxaban and VKA. Dabigatran was associated with a reduced MH risk compared to both Rivaroxaban and VKA.
UNASSIGNED: We systematically investigated two databases (Medline, Embase) until April of 2021, gathered observational studies and extracted hazard ratios (HRs) with 95% confidence intervals (CI) on our outcome of interest. Additional subgroup analyses according to DOAC dosing, prior diagnosis of chronic kidney disease, prior diagnosis of stroke, history of previous use of VKA, the users\' age, the users\' gender and study population geographic region were conducted. All analyses were performed with a random-effects model.
UNASSIGNED: From this search, 55 studies were included and 76 comparisons were performed. The MH risk associated with Rivaroxaban use was higher than the risk with Dabigatran use (HR: 1.32, 95% CI: 1.21-1.45, I 2 : 12.39%) but similar to VKA use (HR: 0.94, 95% CI: 0.87-1.02, I 2 : 76.57%). The MH risk associated with Dabigatran use was lower than the risk with VKA use (HR: 0.75, 95% CI: 0.64-0.90, I 2 : 87.57%). The MH risk associated with Apixaban use was lower than the risk with Dabigatran use (HR: 0.75, 95% CI: 0.64-0.88, I 2 : 58.66%), with Rivaroxaban use (HR: 0.58, 95% CI: 0.50-0.68, I 2 : 74.16%) and with VKA use (HR: 0.60, 95% CI: 0.55-0.65, I 2 : 58.83%). Our aforementioned subgroup analyses revealed similar results.
UNASSIGNED: All in all, Apixaban was associated with a reduced MH risk compared to Dabigatran, Rivaroxaban and VKA. Dabigatran was associated with a reduced MH risk compared to both Rivaroxaban and VKA.
摘要：
■现实世界，观察性研究调查了直接口服抗凝剂(DOAC)用于非瓣膜性心房颤动(NVAF)患者大出血(MH)预防卒中的安全性.我们进行了系统评价和荟萃分析，以研究遵循PRISMA指南的DOAC与其他DOAC和维生素K拮抗剂（VKAs）的比较安全性。我们根据国际血栓和止血协会声明定义MH，或将其定义为颅内，胃肠,泌尿生殖系统,呼吸,在使用国际疾病统计分类代码进行患者选择的研究中，空洞和肌肉骨骼出血。
■我们系统地调查了两个数据库(Medline，Embase），直到2021年4月，收集观察性研究并提取风险比（HR），对我们感兴趣的结果有95％的置信区间（CI）。根据DOAC给药的其他亚组分析，先前诊断为慢性肾脏病，中风的先前诊断，以前使用VKA的历史，用户年龄，进行了用户的性别和研究人口地理区域。所有分析均采用随机效应模型进行。
■从这个搜索，纳入55项研究，进行76项比较。使用利伐沙班的MH风险高于使用达比加群的风险（HR：1.32，95％CI：1.21-1.45，I2：12.39％），但与使用VKA相似（HR：0.94，95％CI：0.87-1.02，I2：76.57％）。使用达比加群的MH风险低于使用VKA的风险（HR：0.75，95％CI：0.64-0.90，I2：87.57％）。与使用阿哌沙班相关的MH风险低于使用达比加群的风险（HR：0.75，95％CI：0.64-0.88，I2：58.66％），使用利伐沙班（HR：0.58，95％CI：0.50-0.68，I2：74.16％）和使用VKA（HR：0.60，95％CI：0.55-0.65，I2：58.83％）。我们前述的亚组分析揭示了类似的结果。
■所有，与达比加群相比，阿哌沙班的MH风险降低，利伐沙班和VKA。与利伐沙班和VKA相比，达比加群降低了MH风险。
■我们系统地调查了两个数据库(Medline，Embase），直到2021年4月，收集观察性研究并提取风险比（HR），对我们感兴趣的结果有95％的置信区间（CI）。根据DOAC给药的其他亚组分析，先前诊断为慢性肾脏病，中风的先前诊断，以前使用VKA的历史，用户年龄，进行了用户的性别和研究人口地理区域。所有分析均采用随机效应模型进行。
■从这个搜索，纳入55项研究，进行76项比较。使用利伐沙班的MH风险高于使用达比加群的风险（HR：1.32，95％CI：1.21-1.45，I2：12.39％），但与使用VKA相似（HR：0.94，95％CI：0.87-1.02，I2：76.57％）。使用达比加群的MH风险低于使用VKA的风险（HR：0.75，95％CI：0.64-0.90，I2：87.57％）。与使用阿哌沙班相关的MH风险低于使用达比加群的风险（HR：0.75，95％CI：0.64-0.88，I2：58.66％），使用利伐沙班（HR：0.58，95％CI：0.50-0.68，I2：74.16％）和使用VKA（HR：0.60，95％CI：0.55-0.65，I2：58.83％）。我们前述的亚组分析揭示了类似的结果。
■所有，与达比加群相比，阿哌沙班的MH风险降低，利伐沙班和VKA。与利伐沙班和VKA相比，达比加群降低了MH风险。
